UK: Statins Over The Counter Despite Little Evidence of Health Benefit

In the midst of growing concerns over the side effects of statin drugs and mounting numbers of cases of muscle related and other problems in people taking these drugs, the UK Health Secretary John Reid is "about to give [over-the-counter statin sales] the green light", according to an article by Reuters.

Red Flags Weekly says in its "daily scream" for May 10, that

"there is little evidence to suggest that [statins] provide an overall health benefit role in primary prevention. Putting statins on an OTC basis will be a reckless experiment with possibly dire consequences. This notion of having pharmacists do a quick Q&A with clients is disgraceful and shows - once again - beyond any shade of doubt that medicine has become a huge and reckless experiment, benefitting Big Pharma's bottom line. This all has to do with drug companies making up lost sales because their statin products are going off-patent. Merck, for example, lost its patent protection for Zocor last year. There will be hell to pay for this."

Medicine has indeed been taken over by Big Pharma and is run as a profit-oriented business with disease. By necessity, health is the first victim of this sad state of affairs and as Red Flags points out, our pocketbook is next in line. No wonder that countries cannot pay for their national health systems any more. We are financing a genocidal industry that is making us sicker and sicker!

Explore earlier articles in this site's pharma section for background.

See also:

Thursday, September 23, 2004
Groups want cholesterol guidelines probe By THE ASSOCIATED PRESS - A consumer group and 35 doctors and scientists asked the federal government Thursday to convene an independent review of the science that led to new guidelines urging wider use of cholesterol-lowering statin drugs.

Statinalert Org

Vitamin C Foundation - Statin Alert

Statins soon to be over-the-counter drugs in the UK

Cholesterol drug move worries doctors

Prescription-Less Cholesterol Drugs Sought

http://apnews.myway.com/article/20040804/D84831AG0.html

Group: Crestor Side Effect Report Delayed

Aug 3, 8:40 PM (ET)

WASHINGTON (AP) - A drug company illegally delayed reporting side effects linked to its anti-cholesterol drug Crestor, a consumer advocate contended Tuesday in urging a Food and Drug Administration investigation.

It's the latest attack on Crestor by the private group Public Citizen, which argues that Crestor is riskier than its competitors and should be banned.

FDA requires drug makers to reveal reports of serious and unexpected side effects within 15 days of learning about them. While those reports don't prove a drug was to blame, FDA evaluates them to determine whether a medicine is riskier than initially thought.

Public Citizen's Dr. Sidney Wolfe charged that AstraZeneca delayed its reports to the FDA by as long as 97 days. The company ultimately reported that 19 Crestor users suffered an often life-threatening muscle-destroying condition - and filed four reports of kidney failure.

The delays "have unquestionably impaired FDA's ability to promptly assess the safety of this uniquely dangerous drug," Wolfe wrote FDA Acting Commissioner Lester Crawford Tuesday.

AstraZeneca insists that Crestor is no more risky than other cholesterol-lowering "statin" drugs, and that it followed FDA rules. The company says it wasn't subject to the 15-day deadline because the side effects were mentioned on the drug's label.

Wolfe countered that Crestor's label implies the muscle-destroying side effect occurs only with an unapproved high dose. The company's own reports, however, implicate far lower doses. The drug's label only mentions kidney failure in passing, Wolfe said.

FDA hasn't formally determined whether AstraZeneca should meet the 15-day deadline, said Dr. Mary Parks, medical officer.

So far, the agency says it sees no signal that Crestor is riskier than other statins, which all can cause rare cases of the muscle side effect.

 

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posted by Sepp Hasslberger on Wednesday May 12 2004
updated on Friday December 3 2010

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Readers' Comments

Comment by e-mail from a friend in the UK:

This article certainly shows, in my opinion, the road that many pharmaceutical companies would like to take [with the acquiescence of the state, of course]. 

Categorise all food supplements as quasi-medicines; categorise more and more controlled medicines as uncontrolled medicines; thus allowing both of the above to be conflated under the aegis of 'controlled health products'. Then, be allowed to control the whole market and sell them all quite freely at the local pharmacy at vastly inflated profits.

Posted by: Sepp on May 13, 2004 09:32 AM

 

The following is a reply to a BMJ opinion piece about medical harm. I am copying it here because the discussion adds important information on statins.

First, do more good than harm - OTC statins

2 July 2004

Malcolm E Kendrick,
Medical Director Adelphi Lifelong Learning
Adelphi Mill Bollington SK10 5JB

You may justify doing harm to do good e.g. drilling a hole in the skull to drain a subdural hematoma. But when one is doing no good, the only possibility left is harm.

So it seems surprising that the BMJ remains silent on a hugely important, and potentially very harmful, development. Namely, OTC statins. Statins have achieved a remarkable status as the new 'wonder drug.' The reality, however, is somewhat more prosaic.

For example, in no clinical trial done so far, have statins reduced overall mortality in women. This includes the much publicised 4S, and HPS studies. In fact in the 4S study slightly more women died in the treatment arm; the HPS authors will not publish overall mortality rates in women, but it appears there was no benefit.

Equally, in men, none of the primary prevention trials using statins have been shown to reduce overall mortality rate. A report last year by the British University of Columbia (part of the Cochrane collaboration), concluded that statins have not been shown to provide an overall health benefit in primary prevention(1).

In reality, there are only two groups where statins have been demonstrated to reduce both CV morality and overall mortality: men with a history of CHD, and men with diabetes (regardless of cholesterol levels). It is difficult to establish the exact prevalence of these groups in the UK (there is some overlap, no doubt). However, a Scottish study reported that men with IHD/Angina represented 6.2% of the adult population; and that diabetes had a prevalence of 2.8% (2)

Scotland has a higher rate of CHD than England, not lower. But even if do extrapolate the Scottish figures (and assume no overlap between IHD and diabetes) to the rest of the UK, this still means that less than 10% of adult males in the UK, or less than 5% of the total adult population, will gain any overall health benefit from using statins.

This would not matter a great deal if statins had no side-effects. But they do have some major, and highly unpleasant side-effects up to and including death from rhabdomyolysis. They create muscle pain/myopathy in up to ten per cent, and there is a high incidence of liver function disorder, and neuropathy. Reports in the USA suggest that they may cause transient global amnesia.

Most worrying for an OTC drug, is that fact that statins appear to be extremely teratogenic. A study reported in the NEJM (3) found a very high percentage of severe birth defects in children born to women exposed to statins in the first trimester. Defects such as duplication of the spinal cord, spina bifida, holoprosencephaly, bone shortening and aplasia.

Whilst statins are contradindicated in pregnancy, this is a common warning, sometimes ignored, and it will be missed (or dismissed) by almost anyone buying a statin OTC. The very fact of making a drug OTC suggests that it must be very safe. Therefore it is inevitable that a number of women will use OTC statins, unaware of the true risk they are taking if they fall pregnant.

In short, the evidence from clinical trials suggests that less than 5% of the adult population can gain any benefit from taking statins. The remaining 95% will not only gain no health benefit, they will also risk suffering side-effects, some of which are extremely severe. A number of women will fall pregnant whilst on statins, resulting in severe birth defects in their children.

First do no harm? Before risking harm it is a good idea to ensure that you may actually be doing some good in the first place. OTC statins have the potential to harm a great number of people, whilst benefiting only a few. The medical profession should try to reverse this decision.

References

(1) trials. http://www.ti.ubc.ca/pages/letter48.htm

(2) www.show.scot.nhs.uk/scottishhealthsurvey/sh802-01.html#23

(3) Central Nervous System and Limb Abnormalities in Case Reports of First -Trimester Statin Exposure NEJM April 8th 2004 1579 - 1582.

Posted by: Sepp on July 8, 2004 04:27 PM

 

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